Food And
Drug Administration
Center For Biologics Evaluation And Research
Vaccines And Related Biological Products Advisory Committee Meeting
DRAFT AGENDA
Open Session
9:05 Administrative
Matters Christine Walsh, R.N., FDA
Safety and Efficacy of GARDASIL® (Human Papillomavirus [Types 6,
11, 16, 18] Recombinant Vaccine) Manufactured by Merck
Presentation of Questions
9:30 Sponsor
Presentation Eliav Barr, M.D./
Merck Research Laboratories
Patrick Brill-Edwards, M.D.
11:00 FDA
Presentation Nancy
Miller M.D., FDA
12
1:30 p.m. Open
Public Hearing
2:30 FDA
Presentation of Questions Nancy Miller, M.D., FDA
2:40 Committee
Discussion of FDA Questions
Committee Recommendations